Online Business Bureau News

FDA warns topical cream makers on blends

WASHINGTON (UPI) -- U.S. authorities are warning five firms to stop compounding and distributing standardized versions of topical anesthetic creams.

The Food and Drug Administration said Wednesday it was warning Triangle Compounding Pharmacy, University Pharmacy, Custom Scripts Pharmacy, Hal's Compounding Pharmacy and New England Compounding Center to stop such activity with creams marketed for general distribution rather than responding to the unique medical needs of individual patients.

Firms that do not resolve violations in FDA warning letters risk enforcement such as injunctions against continuing violations and seizure of illegal products.

The FDA said it is concerned about the serious public health risks related to compounded topical anesthetic creams. Exposure to high concentrations of local anesthetics, like those in compounded topical anesthetic creams, can cause grave reactions including seizures and irregular heartbeats.

Two deaths have been connected to compounded topical anesthetic creams made by Triangle Compounding Pharmacy and University Pharmacy.